Plugging hemostat and plugging hemostasis system

Abstract

The utility model relates to a plugging hemostat and a plugging hemostasis system, the plugging hemostat is used for plugging a perforation of a biological tissue channel, and the plugging hemostat comprises: a cannula assembly comprising an inner tube and an outer tube which are sleeved inside and outside; the deformation part is connected to the far end of the inner tube; the plugging piece is located on the periphery of the inner pipe, located at the near end of the deformation piece and used for plugging the penetrating hole, the plugging piece sequentially comprises a primary release section and a secondary release section from the far end to the near end, the primary release section is exposed out of the outer pipe, and the secondary release section is located in a radial gap between the inner pipe and the outer pipe; and the pushing piece is slidably arranged on the inner tube in a sleeving mode, located at the near end of the plugging piece and used for pushing the plugging piece to the far end. The primary release section of the plugging hemostat can expand in advance before the secondary release section, so that the plugging piece is accurately positioned to the far end, the plugging piece is allowed to be designed to be longer, and the plugging effect is better.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a occlusion hemostat and an occlusion hemostasis system. Background Technology

[0002] The occlusion device is suitable for patients undergoing diagnostic or interventional endovascular surgery via femoral artery puncture. It utilizes a balloon catheter combined with a standard surgical sheath to deliver an external occlusion device to achieve hemostasis at the femoral artery puncture site. The occlusion device is made of a rubbery material that expands upon contact with subcutaneous fluid to seal the bleeding site, thereby achieving hemostasis.

[0003] Ideally, a occlusive hemostat can accurately release the occlusive element to the intended deployment location, unaffected by blood flow. However, in actual surgical procedures, improper operation may cause the occlusive element to move away from the vascular puncture site due to blood flow, resulting in the occlusive element being exposed under the skin or the occlusion failing. Utility Model Content

[0004] Therefore, it is necessary to provide a clogging and hemostatic device to address the aforementioned technical problems.

[0005] This application relates to a hemostatic device for sealing perforations in biological tissue channels, comprising:

[0006] A sleeve assembly, comprising an inner tube and an outer tube that are separated into inner and outer sleeves;

[0007] Deformable element, connected to the distal end of the inner tube;

[0008] A plugging component, located on the outer periphery of the inner tube and near the proximal end of the deformable component, is used to plug the perforation. The plugging component includes a primary release section and a secondary release section from the distal end to the proximal end. The primary release section is exposed to the outer tube, and the secondary release section is located within the radial gap between the inner tube and the outer tube.

[0009] The pusher is slidably sleeved on the inner tube and located near the end of the sealing member, and is used to push the sealing member to the far end.

[0010] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0011] Optionally, the sealing element has:

[0012] Initial state;

[0013] In the first release state, only the single release segment expands radially;

[0014] In the second release state, both the primary release section and the secondary release section are exposed to the outer tube and expand radially.

[0015] Optionally, the primary release segment and the secondary release segment are each:

[0016] It is sheet-like, initially folded in a meandering manner and threaded onto the inner tube;

[0017] It may be cylindrical, and initially fitted onto the inner tube.

[0018] Optionally, along the axial direction of the sleeve assembly, the total length of the plugging element is 5 to 30 mm, wherein the length of the primary release section is at least 35% of the total length of the plugging element.

[0019] Optionally, the length of the primary release section is 40% to 60% of the total length of the sealing element.

[0020] Optionally, the deformable element has a contracted state adapted to intervention and delivery, and an expanded state after radial deformation. The deformable element is a metal mesh or a balloon body communicating with the inner tube.

[0021] Optionally, the sealing element has directional channels inside to guide its own deformation.

[0022] Optionally, the primary release section and the secondary release section can be an integral structure or separate structures, wherein:

[0023] The directional channel within the primary release section extends in the radial direction;

[0024] The directional channels within the secondary release section extend along the axial direction.

[0025] This application provides a closure and hemostasis system, including a sheath and a closure and hemostasis device as described in this application.

[0026] Optionally, in the first release state, the secondary release section of the sealing member is located in the radial gap between the inner tube and the outer tube, and the primary release section is located in the radial gap between the inner tube and the sheath.

[0027] The occlusion hemostatic device and occlusion hemostatic system of this application have at least one of the following technical effects:

[0028] The primary release segment of the occlusion device of this application allows the blood to expand before the secondary release segment, so as to accurately position the occlusion element to the distal end, allowing the occlusion element to be designed to be longer and the occlusion effect to be better. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the occlusion hemostat in one embodiment of this application;

[0030] Figure 2 This is a schematic diagram of the sheath structure used in conjunction with the occlusion hemostasis device to form an occlusion hemostasis system;

[0031] Figure 3 This is a partial cross-sectional view of the cannula assembly of a clogging hemostat in the prior art;

[0032] Figure 4 This is a partial assembly diagram of the cannula assembly of a clogging hemostat in the prior art;

[0033] Figure 5 This is a schematic diagram illustrating the use of the occlusion hemostat in one embodiment of this application;

[0034] Figure 6 This is a schematic diagram illustrating the use of the occlusion hemostat in one embodiment of this application;

[0035] Figure 7 This is a partial cross-sectional view of the cannula assembly of the occlusion hemostat in one embodiment of this application;

[0036] Figure 8 This is a schematic diagram illustrating the use of the occlusion hemostat in one embodiment of this application;

[0037] Figure 9 This is a schematic diagram illustrating the use of the occlusion hemostat in one embodiment of this application;

[0038] Figure 10 This is a schematic diagram illustrating the use of the hemostatic occlusion device in one embodiment of this application.

[0039] The annotations in the figure are explained as follows:

[0040] 110. Inner tube; 115. Radial clearance; 120. Outer tube;

[0041] 130. Sealing assembly; 131. Sealing tube; 132. Sealing sleeve;

[0042] 200. Deformable component; 300. Sealing component; 310. Primary release section; 320. Secondary release section; 400. Pushing component;

[0043] 500. Control handle; 510. Two-way valve;

[0044] 600, sheath; 601, radial clearance; 610, instrument channel; 620, hemostatic valve; 621, sealing port. Detailed Implementation

[0045] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0046] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0047] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0048] In this application, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0049] In this application, the terms “comprising” and “having”, and any variations thereof, are intended to cover non-exclusive inclusion, for example, a system, product, or device that includes a series of units is not necessarily limited to those units that are explicitly listed, but may include other units that are not explicitly listed or that are inherent to such products or devices.

[0050] In the field of interventional medical device technology, the orientation closer to the operator is generally defined as proximal or proximal side, and the orientation farther from the operator is defined as distal or distal side. The direction of the rotational axis of objects such as cylinders and tubes is defined as the axial direction. Radial direction refers to the direction perpendicular to the axial direction and along the diameter or radius. Circumferential direction is the direction around the axis of objects such as cylinders and tubes (perpendicular to the axis and also perpendicular to the cross-sectional radius).

[0051] See Figure 1This application provides a occlusion hemostat in one embodiment, used to seal perforations in biological tissue channels (such as blood vessels). The occlusion hemostat typically includes a cannula assembly, a deformable element 200, an occlusion element 300, and a pusher element 400. The cannula assembly includes an inner tube 110 and an outer tube 120, which are disposed inner and outer respectively. The deformable element 200 is connected to the distal end of the inner tube 110. The occlusion element 300 is located on the outer periphery of the inner tube 110 and proximal to the deformable element 200, used to seal perforations in biological tissue channels. The pusher element 400 may be, for example, a hollow tube sleeved on the outer surface of the inner tube 110 and slidingly engaged with the inner tube 110.

[0052] The proximal end of the occlusion device has a control handle 500 and a two-way valve 510. When the deformable element 200 is selected as a balloon body communicating with the inner tube 110, fluid inflates into the balloon body through the two-way valve 510 and the inner tube 110. A sealing assembly 130 is fitted onto the outer surface of the outer tube 120.

[0053] See Figure 2 The occlusion hemostat and the sheath 600 together constitute an occlusion hemostasis system. The sheath 600 is used to provide an instrument channel 610 for the perforation of the cannula assembly into biological tissue. A hemostatic valve 620 is connected to the proximal end of the sheath 600. The hemostatic valve 620 has a sealing port 621. The sealing assembly 130 includes a sealing tube 131 that can extend into the sealing port 621, and a sealing sleeve 132 connected to the sealing tube 131 and located at the proximal end of the sealing tube 131.

[0054] See Figures 1-6 The process of using the occlusion hemostat is as follows: (1) For perforations of biological tissue channels, such as vascular perforations, the distal end of the sheath 600 enters the blood vessel along the perforation, while the proximal end of the sheath 600 is exposed outside the body. The sheath 600 provides an instrument channel 610. (2) The cannula assembly of the occlusion hemostat is inserted into the blood vessel along the instrument channel 610. The sealing tube 131 is inserted into the sealing port 621, and the sealing sleeve 132 is located at the proximal end of the sealing port 621. The outer tube 120 protects the occlusion element 300 and passes through the hemostatic valve 620 of the sheath 600. The outer tube 120 continues to slide distally relative to the sealing sleeve 132 until the deformable element 200 extends out of the distal end of the sheath 600. (3) The deformable element 200 is driven to deform, and the entire cannula assembly is retracted so that the deformable element 200 is close to the inner wall of the blood vessel. The working state at this time is as follows: Figure 5 As shown. (4) Retract the outer tube 120 and sheath 600, keep the inner tube 110 in place, and expose the distal end of the pusher 400. The working state at this time is as follows. Figure 6 As shown. (5) Push the sealing component 300, and use the push component 400 to push it. The sealing component 300 is pushed and remains in place to absorb liquid and expand to stop bleeding. (6) The deformed component 200 returns to its original state, and the inner tube 110 is withdrawn. The operation is completed.

[0055] See Figure 4and Figure 6 In the prior art, the occlusion element 300 is entirely located within the radial gap 115 between the inner tube 110 and the outer tube 120. During the execution of "(4) withdrawing the outer tube 120 and the sheath 600, and (5) pushing the occlusion element 300", when the occlusion element 300 is pushed, it expands radially outward and comes into contact with the blood, which can easily lead to the occlusion position being far from the inner wall of the blood vessel, insufficient occlusion, the occlusion element 300 being exposed to the skin, or occlusion failure. This situation is particularly obvious when the patient's subcutaneous tissue is thinned.

[0056] See Figure 7 One embodiment of this application provides a occlusion hemostat. The occlusion member 300 of the occlusion hemostat includes a primary release section 310 and a secondary release section 320 from distal to proximal. The primary release section 310 is exposed to the outer tube 120, and the secondary release section 320 is located within the radial gap 115 between the inner tube 110 and the outer tube 120. A pusher 400 is slidably sleeved on the inner tube 110 and located at the proximal end of the occlusion member 300, and is used to push the occlusion member 300 distally.

[0057] One embodiment of this application provides a occlusion hemostasis system, including an occlusion hemostat and a sheath 600. In a first release state, the occlusion member 300 has a secondary release section 320 located in the radial gap 115 between the inner tube 110 and the outer tube 120, and a primary release section 310 located in the radial gap 601 between the inner tube 110 and the sheath 600.

[0058] See Figures 8-10 In the occlusion hemostat and occlusion hemostat system provided in the various embodiments of this application, before performing “(4) withdrawing the outer tube 120 and the sheath 600 and (5) pushing the occlusion member 300”, the occlusion member 300 includes a pre-compression stage implemented using the occlusion hemostat provided in the corresponding embodiment.

[0059] like Figure 8 As shown, the primary release segment 310 is exposed to the outer tube 120 and is located within the radial gap 601 between the inner tube 110 and the sheath 600. At this time, the primary release segment 310 contacts the blood and pre-expands relative to the secondary release segment 320, allowing the occluder 300 to be accurately positioned distally via the first and / or second method, enabling the occluder 300 to be designed to be longer and easier to seal perforations.

[0060] The first method involves the primary release section 310 pre-expanding, which naturally pulls the secondary release section 320 towards the distal end. The second method is as follows... Figure 9 Compared to Figure 8As shown in the changing state, the outer tube 120 can be pushed distally, and the pushing outer tube 120 pre-compresses the pre-expanded primary release section 310. The occlusion element 300 is further radially expanded outward by the pushing and compression of the outer tube, pressing tightly against the sidewall of the perforation, so that the occlusion element 300 can be accurately positioned and deployed on the inner wall of the blood vessel. See also Figure 10 and Figure 6 In this embodiment, the occlusion position of the primary release segment 310 is accurately located to the inner wall of the blood vessel. When using occlusion elements 300 of the same length: ... Figure 6 The existing technical solution shown, after completion of the sealing, has an axial length L1 along the intervention direction. For example... Figure 10 The improved technical solution shown has an axial length of L2 along the intervention direction after the closure is completed. L2 is less than L1, which allows the closure component 300 to be designed to be longer, resulting in a larger overall volume after expansion and further improving the closure success rate.

[0061] Regarding the occlusion element 300, its operation includes an initial state, a first release state, and a second release state. In the initial state, neither the primary release segment 310 nor the secondary release segment 320 of the occlusion element 300 expands. In the first release state, only the primary release segment 310 expands radially. In the second release state, both the primary release segment 310 and the secondary release segment 320 are exposed to the outer tube 120 and expand radially. The occlusion element 300 can be made of bioabsorbable materials, such as collagen (i.e., a water-absorbing and swelling material), thereby achieving excellent hemostasis after sealing the perforation. Furthermore, bioabsorbable materials can degrade within human tissue, offering high safety.

[0062] The deformable element 200 has a contracted state adapted for interventional delivery and an expanded state after radial deformation. The deformable element 200 is either a metal mesh or a balloon body communicating with the inner tube 110. When the deformable element 200 is a balloon body communicating with the inner tube 110, the inner tube 110 provides a fluid channel for inflating the balloon body with fluids such as saline, causing it to move from the contracted state to the expanded state. When the deformable element 200 is a metal mesh, the occlusion hemostat includes a traction wire located in the inner tube 110, connected to the distal end of the deformable element 200, for traction to drive the deformable element 200 into the expanded state.

[0063] The primary release section 310 and the secondary release section 320 of the sealing component 300 are respectively plate-shaped or cylindrical. When the sealing component 300 is plate-shaped, it is initially folded and looped around the inner tube 110. When the sealing component 300 is cylindrical, it is initially fitted onto the inner tube 110.

[0064] Along the axial direction of the casing assembly, the total length of the plugging element 300 is 5–30 mm, wherein the length of the primary release section 310 is at least 35% of the total length of the plugging element 300. Further, the length of the primary release section 310 is 40%–60% of the total length of the plugging element 300.

[0065] The sealing component 300 has internal directional channels that guide its own deformation. A section of the sealing component 300 with directional channels can expand in a predetermined direction. Compared to free expansion, directional expansion provides a superior sealing effect for perforations. Specifically, the primary release section 310 and the secondary release section 320 can be an integral structure or separate structures. The orientation of the directional channels can be configured according to the application scenario; for example, the directional channels in the primary release section 310 can extend radially, while the directional channels in the secondary release section 320 can extend axially.

[0066] The occlusion hemostat and occlusion hemostasis system provided in the embodiments of this application include a primary release section 310 that can expand before the secondary release section 320, allowing the occlusion member 300 to be accurately positioned distally. This allows the occlusion member 300 to be designed to be longer, resulting in better occlusion. The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered within the scope of this specification. When technical features from different embodiments are embodied in the same drawing, it can be considered that the drawing also simultaneously discloses combinations of the various embodiments involved.

[0067] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. A occlusive hemostat for sealing perforations in biological tissue channels, characterized in that, include: A sleeve assembly, comprising an inner tube and an outer tube that are separated into inner and outer sleeves; Deformable element, connected to the distal end of the inner tube; A plugging component, located on the outer periphery of the inner tube and near the proximal end of the deformable component, is used to plug the perforation. The plugging component includes a primary release section and a secondary release section from the distal end to the proximal end. The primary release section is exposed to the outer tube, and the secondary release section is located within the radial gap between the inner tube and the outer tube. The pusher is slidably sleeved on the inner tube and located near the end of the sealing member, and is used to push the sealing member to the far end.

2. The occlusion and hemostasis device as described in claim 1, characterized in that, The sealing component has: Initial state; In the first release state, only the single release segment expands radially; In the second release state, both the primary release section and the secondary release section are exposed to the outer tube and expand radially.

3. The occlusion and hemostasis device as described in claim 2, characterized in that, The primary release segment and the secondary release segment are respectively: It is sheet-like, initially folded in a meandering manner and threaded onto the inner tube; It may be cylindrical, and initially fitted onto the inner tube.

4. The occlusion and hemostasis device as described in claim 2, characterized in that, Along the axial direction of the sleeve assembly, the total length of the plugging element is 5 to 30 mm, wherein the length of the primary release section is at least 35% of the total length of the plugging element.

5. The occlusion and hemostasis device as described in claim 4, characterized in that, The length of the primary release section is 40% to 60% of the total length of the sealing component.

6. The occlusion and hemostasis device as described in claim 2, characterized in that, The deformable element has a contracted state adapted to intervention and delivery, and an expanded state after radial deformation. The deformable element is a metal mesh or a balloon body connected to the inner tube.

7. The occlusion and hemostasis device as described in claim 2, characterized in that, The sealing component has directional channels inside that guide its own deformation.

8. The occlusion and hemostasis device as described in claim 7, characterized in that, The primary release section and the secondary release section can be integrated into one unit or separate units, wherein: The directional channel within the primary release section extends in the radial direction; The directional channels within the secondary release section extend along the axial direction.

9. A occlusion and hemostasis system, characterized in that, Includes a sheath and a clogging hemostat as described in any one of claims 2 to 8.

10. The occlusion and hemostasis system as described in claim 9, characterized in that, In the first release state, the secondary release section of the sealing member is located in the radial gap between the inner tube and the outer tube, and the primary release section is located in the radial gap between the inner tube and the sheath.

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